Forms/Applications

Prior to beginning research in the Clinical Research Center (G-5035) or Clinical Research Infusion Center (G-8169), researchers are required to submit an application for approval by the CRC. Instructions are detailed below. It is most helpful to address issues of concern prior to protocol submission. Questions about the application process or use of CRC services should be addressed to the following CRC personnel:

Application Process:  Mary Little at (585) 275-0653 

Nursing and DXA: Ann Miller at (585) 275-2907

Nutrition Research: Nellie Wixom at (585) 275-3918 

Coordinator Services: JoAnne VanBuskirk at (585) 275-4729

• Coordinator Services
• Protocol Approval Process
• Application Process
• Protocol Amendments
• Fees: Effective until 6/30/23
• Fees: Effective 7/1/23 to 6/30/24
• Forms

Coordinator Services

If you need coordinator services for a protocol that will be using other CRC services, please follow the New Protocol Submissions steps below.  If you need coordinator services for protocols that will not be using other CRC services, please complete this application and submit it electronically to UR CTSI.  If you need service for more than one protocol, complete one application per protocol.

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Protocol Approval Process

The CRC must approve a protocol prior to conducting research procedures on study subjects on the CRC or using CRC resources. 

Please note the following information about the CRC protocol submission/review process:

• IRB (RSRB, single IRB, or central IRB) approval is required prior to CRC review.
• CRC review consists of a feasibility review for the requested use of CRC services or resources. The CRC is committed to prompt review of the protocol for feasibility.
  • The review process starts upon receipt of the CRC application, IRB approval, and all required study documents.
  • If there are no questions or issues needing clarification during the review process, the protocol can be approved and a CRC protocol number can be provided by the fifth business day after CRC receipt of the protocol.
  • If the PI responds promptly to any questions or items of clarification arising from the review, it is estimated that the turnaround time for the feasibility review would be a total of two weeks from CRC receipt of the complete protocol submission package.
  • The CRC strongly encourages study teams to work with the CRC staff prior to protocol submission to work out potential issues and reduce time to approval.

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New Protocol Submissions

• Protocols reviewed by the RSRB:
  1. When filling out the protocol application in the Click IRB system, indicate that the study will use the resources of the CRC. This will provide the CRC with access to the study documents, IRB approval documents, and future amendments.
  2. After RSRB approval has been received, submit the CRC Protocol Submission Application electronically to UR CTSI. If you did not indicate at initial RSRB submission that the study will use the resources of the CRC, attach the required study documents detailed in the table below, as well as the departmental scientific review of the study.
• Protocols reviewed by an IRB external to the University of Rochester – Submit the following documents electronically to UR CTSI:
  • CRC Protocol Submission Application
  • IRB approval
  • IRB-approved consent form(s)
  • Departmental scientific review of the study
  • Required study documents detailed in the table below

Once the required documents are received, the CRC feasibility review will begin.

The table below details the components required for CRC protocol review. The required components are based upon the involvement of the CRC in the study. Incomplete submissions may result in delay of review.

Adding Use of CRC Resources or Services to a Study that has Already Received IRB Approval

Submit the following documents electronically to UR CTSI:

• CRC Protocol Submission Application
• IRB approval
• IRB-approved consent form(s)
• Departmental scientific review of the study
• Required study documents detailed in the table above

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Protocol Amendments

• When a protocol amendment impacts the CRC, a CRC Amendment Submission Form and supporting documentation need to be submitted to UR CTSI for CRC review. It is the responsibility of the study team to communicate protocol changes that impact the CRC.

Regardless of whether or not an amendment directly impacts the CRC, if the protocol or consent form is revised, a revised copy of the protocol or consent form needs to be forwarded to UR CTSI.

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Fees

• Fees for use of the Clinical Research Center are substantially subsidized, up to 80% of costs. View the current fee schedule.
• The Clinical Research Center provides cost estimates to assist in budget development for grants or industry-funded protocols. To request a cost estimate, please submit a CRC Cost Estimate Request Form to UR CTSI, along with the protocol or portion of the grant detailing the research study.

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Forms

• CRC Protocol Submission Application
• CRC Amendment Submission Form
• CRC Cost Estimate Request Form
• Application Information and General Instructions. There are several steps to starting a study on the CRC. This document outlines the steps that will help to ensure a well-planned study and a smooth initiation.
• Preparing-for-a-CRC-In-service-Form
• CRC-Subject-Visit-Checklist-for-Coordinators
• Patient Care Orders - 1 open text section, Patient Care Orders - 2 open text sections, Patient Care Orders - 3 open text sections
• Request for Coordinator Services
• Patient Care Orders - 4 open text sections. Once completed and signed appropriately, these templates can be used for Patient Care Orders. Any questions regarding this form should be directed to CRC Nurse Manager, Ann Miller at (585) 275-2907.
• Study Visit Orders (to be used for studies that are minimal risk and have no medications ordered)
• Suggested Wording for CRC Procedures for Protocols/Consents. This document details research procedures commonly used on the CRC and specific descriptive wording, which can be used in protocol and informed consent.

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